Periodontal DiseasePhase 4NCT02670135
Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
A Phase 4 study testing Triclosan Containing Toothpaste and Triclosan Free Toothpaste in people with Periodontal Disease and Systemic Inflammatory Markers, run by Colgate Palmolive.
Trial summary
This is a single center, double blinded, randomized, controlled trial. Qualified subjects will be enrolled and randomized to either one of the two study groups: a) using 0.3% triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice (copolymer/fluoride/no triclosan) twice daily. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Disease, Systemic Inflammatory Markers
- What is being tested?
- Triclosan Containing Toothpaste and Triclosan Free Toothpaste
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Aug 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject males or females 18 to 50 years old.
- Availability for the 12 months duration of the clinical research study.
- Subject able and willing to follow study procedures and instructions.
- Subject read, understood and signed an informed consent form.
- Subject present with at least 20 natural teeth in the functional dentition (excluding third molars).
- Initial probing pocket depth of >4mm in at least one tooth/quadrant.
- Good general health.
- Subjects willing to disclose information on medication.
Who cannot join
- Subject with concomitant periodontal therapy 6 months prior to enrollment.
- Subject with orthodontic appliances.
- Subject chronically treated (i.e. two weeks or more) with any medication known to affect inflammation or periodontal status or within one month of the first examination*.
- Subject treated with antibiotics within 3 months prior to enrollment.
- Subject necessitating antibiotic prophylaxis.
- Subject with active infectious diseases (hepatitis, human immunodeficiency virus or Tuberculosis) or subject is immunocompromised as determined by the Investigator*.
Show all 11Show fewer
- Subject with known allergy to oral care products or ingredients in oral care products.
- Subject with gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque and calculus, or soft or hard tissue tumor of the oral cavity (determined by the examiner).
- Subject diagnosed with aggressive periodontitis or acute necrotizing ulcerative gingivitis.
- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Subject pregnant at point of enrollment.
About this study
This is a single center, double blinded, randomized, controlled trial. Qualified subjects will be enrolled and randomized to either one of the two study groups: a) using 0.3% triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice (copolymer/fluoride/no triclosan) twice daily.
Read the detailed description
The objective of this study is to comparatively evaluate the effects of Colgate Total® toothpaste with triclosan (commercially sold in Israel) and triclosan-free matching placebo toothpaste on markers of inflammation in the bloodstream and to correlate these findings with periodontal disease status in the oral cavity, as determined by the parameters assessed. Periodontal parameters (periodontal pocket dept (PPD), Clinical Attachment loss (CAL)) will be assessed at baseline and after 2, 6 and 12 months of product use. Peripheral blood samples will be drawn from the subjects at baseline and after 2, 6 and 12 months to evaluate the effects of tooth brushing on systemic inflammatory markers (CRP, PGE2, IL-1β, TNF-α).
- Conditions
- Periodontal Disease, Systemic Inflammatory Markers
- Being tested
- Triclosan Containing Toothpaste, Triclosan Free Toothpaste
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triclosan Containing ToothpasteDrug
Also called Active comparator, Total Toothpaste
Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
Triclosan Free ToothpasteDrug
Also called Control toothpaste
Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
| Study group | Role | What they receive |
|---|---|---|
| triclosan free toothpaste | Placebo comparator | Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo Receives: Drug: Triclosan Free Toothpaste |
| Triclosan containing toothpaste | Active comparator | Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base Receives: Drug: Triclosan Containing Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Periodontal Pocket Depth (PPD)
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
Measured: baseline
Periodontal Pocket Depth (PPD)
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
Measured: 2 months
Periodontal Pocket Depth (PPD)
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
Measured: 6 months
Periodontal Pocket Depth (PPD)
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
Measured: 12 months
Clinical Attachment Loss (CAL)
Attachment lost will be measured from index teeth as described in WHO (2013). Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
Measured: baseline
Clinical Attachment Loss (CAL)
Attachment lost will be measured from index teeth as described in WHO (2013). Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
Measured: 2 months
Clinical Attachment Loss (CAL)
Attachment lost will be measured from index teeth as described in WHO (2013). Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
Measured: 6 months
Clinical Attachment Loss (CAL)
Attachment lost will be measured from index teeth as described in WHO (2013). Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
Measured: 12 months
C Reactive Protein (CRP)
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body. Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease. The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
Measured: baseline
C Reactive Protein (CRP)
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body. Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease. The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
Measured: 2 months
C Reactive Protein (CRP)
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body. Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease. The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
Measured: 6 months
C Reactive Protein (CRP)
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body. Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease. The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
Measured: 12 months
Interleukin-1 Beta ( IL-1β)
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer
Measured: baseline
Interleukin-1 Beta (IL-1β)
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer
Measured: 2 months
Interleukin-1 Beta (IL-1β)
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer
Measured: 6 months
Interleukin-1 Beta (IL- 1β)
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer
Measured: 12 months
Tumor necrosis factor - alfa (TNF-α)
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge. Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
Measured: baseline
Tumor necrosis factor - alfa (TNF-α)
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge. Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
Measured: 2 months
Tumor necrosis factor - alfa (TNF-α)
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge. Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
Measured: 6 months
Tumor necrosis factor - alfa (TNF-α)
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge. Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
Measured: 12 months
Prostaglandin E2 (PGE 2)
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
Measured: baseline
Prostaglandin E2 (PGE 2)
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
Measured: 2 months
Prostaglandin E2 (PGE 2)
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
Measured: 6 months
Prostaglandin E2 (PGE 2)
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
Measured: 12 moths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJun 2015
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseaseStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670135
- Sponsor's protocol ID
- CRO-2014-09-CT-ISR-DB
- Status last verified
- Jun 2015
- First submitted
- 28 Jan 2016
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Effects of Colgate Total Toothpaste as Compared to a Matching Placebo on Periodontal Disease and Systemic Inflammatory Markers
- ClinicalTrials.gov ID
- NCT02670135
- Acronym / sponsor ID
- CRO-2014-09-CT-ISR-DB
- Conditions
- Periodontal Disease, Systemic Inflammatory Markers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center, double blinded, randomized, controlled trial. Qualified subjects will be enrolled and randomized to either one of the two study groups: a) using 0.3% triclosan/copolymer/fluoride dentifrice twice daily - b) using a matching control dentifrice (copolymer/fluoride/no triclosan) twice daily.
Detailed description
The objective of this study is to comparatively evaluate the effects of Colgate Total® toothpaste with triclosan (commercially sold in Israel) and triclosan-free matching placebo toothpaste on markers of inflammation in the bloodstream and to correlate these findings with periodontal disease status in the oral cavity, as determined by the parameters assessed. Periodontal parameters (periodontal pocket dept (PPD), Clinical Attachment loss (CAL)) will be assessed at baseline and after 2, 6 and 12 months of product use. Peripheral blood samples will be drawn from the subjects at baseline and after 2, 6 and 12 months to evaluate the effects of tooth brushing on systemic inflammatory markers (CRP, PGE2, IL-1β, TNF-α).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| triclosan free toothpaste | Placebo comparator | Drug: Triclosan Free ToothpasteControl toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo |
| Triclosan containing toothpaste | Active comparator | Drug: Triclosan Containing ToothpasteActive formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject males or females 18 to 50 years old.
- Availability for the 12 months duration of the clinical research study.
- Subject able and willing to follow study procedures and instructions.
- Subject read, understood and signed an informed consent form.
- Subject present with at least 20 natural teeth in the functional dentition (excluding third molars).
Key exclusion criteria (11 listed)
- Subject with concomitant periodontal therapy 6 months prior to enrollment.
- Subject with orthodontic appliances.
- Subject chronically treated (i.e. two weeks or more) with any medication known to affect inflammation or periodontal status or within one month of the first examination*.
- Subject treated with antibiotics within 3 months prior to enrollment.
- Subject necessitating antibiotic prophylaxis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Triclosan Containing ToothpasteAlso: Active comparator, Total ToothpasteActive formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base | Drug | Triclosan containing toothpaste |
| Triclosan Free ToothpasteAlso: Control toothpasteControl toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo | Drug | triclosan free toothpaste |
Primary outcome
Periodontal Pocket Depth (PPD)
Time frame: baseline
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
Periodontal Pocket Depth (PPD)
Time frame: 2 months
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
Periodontal Pocket Depth (PPD)
Time frame: 6 months
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
Periodontal Pocket Depth (PPD)
Time frame: 12 months
PPD examination will be performed using a World Health Organization (WHO) Community Periodontal Index (CPI) periodontal probe in all teeth present as described by WHO (2013). The PPD examination is according to the pocket scores provided here: 0 = Absence of condition, 1 = Pocket 4-5mm, 2 = Pocket 6mm or more, 9 = Tooth excluded, X = Tooth not present (The lower the number the healthier the tissue)
Clinical Attachment Loss (CAL)
Time frame: baseline
Attachment lost will be measured from index teeth as described in WHO (2013). Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
Clinical Attachment Loss (CAL)
Time frame: 2 months
Attachment lost will be measured from index teeth as described in WHO (2013). Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
Clinical Attachment Loss (CAL)
Time frame: 6 months
Attachment lost will be measured from index teeth as described in WHO (2013). Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
Clinical Attachment Loss (CAL)
Time frame: 12 months
Attachment lost will be measured from index teeth as described in WHO (2013). Loss of attachment is recorded by dividing the mouth in sextants, defined by tooth numbers: 18-14, 13-23, 24-28, 38-34, 33-43, and 44-48 Measurements will be recorded as: 0 = 0-3mm, 1 = 4-5mm (CEJ within black band), 2 = 6-8mm (CEJ between upper limit of black band and 8.5mm ring) 3 = 9-11mm (CEJ between 8.5mm ring and 11.5mm ring), 4 = 12mm and more (CEJ beyond 11.5mm ring), X = excluded, 9 = not recorded (The lower the number the healthier the tissue)
C Reactive Protein (CRP)
Time frame: baseline
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body. Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease. The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
C Reactive Protein (CRP)
Time frame: 2 months
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body. Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease. The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
C Reactive Protein (CRP)
Time frame: 6 months
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body. Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease. The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
C Reactive Protein (CRP)
Time frame: 12 months
C-reactive protein is a biomarker found in the blood and measures general levels of inflammation in your body. Inflammation plays a role in the initiation and progression of cardiovascular and potentially periodontal disease. The blood sample will be evaluated using Roche COBAS 6000 C501 system to quantify levels.
Interleukin-1 Beta ( IL-1β)
Time frame: baseline
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer
Interleukin-1 Beta (IL-1β)
Time frame: 2 months
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer
Interleukin-1 Beta (IL-1β)
Time frame: 6 months
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer
Interleukin-1 Beta (IL- 1β)
Time frame: 12 months
Inflammatory biomarker found in blood that may be a factor in oral tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer
Tumor necrosis factor - alfa (TNF-α)
Time frame: baseline
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge. Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
Tumor necrosis factor - alfa (TNF-α)
Time frame: 2 months
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge. Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
Tumor necrosis factor - alfa (TNF-α)
Time frame: 6 months
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge. Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
Tumor necrosis factor - alfa (TNF-α)
Time frame: 12 months
TNF is a pro-inflammatory biomarker that is involved at an early stage inflammatory cascade and is released from mast cells in response to bacterial challenge. Drugs that block the action of TNF have been shown to be beneficial in reducing the inflammation in inflammatory diseases.
Prostaglandin E2 (PGE 2)
Time frame: baseline
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
Prostaglandin E2 (PGE 2)
Time frame: 2 months
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
Prostaglandin E2 (PGE 2)
Time frame: 6 months
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
Prostaglandin E2 (PGE 2)
Time frame: 12 moths
Inflammatory biomarker found in blood and may be a factor in tissue destruction as seen in periodontal disease. Levels will be quantified via the Automated Triturus ELISA Analyzer using Lithium-Heparin Plasma with an Indomethacin Inhibitor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triclosan Containing Toothpaste and Triclosan Free Toothpaste in people with Periodontal Disease and Systemic Inflammatory Markers, run by Colgate Palmolive.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periodontal Pocket Depth (PPD) (time frame: baseline). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2019.